MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® EXCLUDER®AAA ENDOPROSTHESIS; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number	PXA260300
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Aneurysm expansion (4597)
Date of Event	07/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The instructions for use (ifu) for the gore® excluder® conformable aaa endoprosthesis states, adverse events that may occur and / or require intervention include but are not limited to: endoleak, endoprosthesis: occlusion;.Occlusion of device or native vessel, aneurysm enlargement concomitant medical products: as gore was unable to determine which device was involved in the event if any; additional device(s) implanted include: pxa260300/9809382, udi: (b)(4), plc271000/11820549, udi: (b)(4), rmt261418/12063986, udi: (b)(4), pxc141400/12104167, udi: (b)(4), pxc121400/12117771, udi: (b)(4), pxl161207/11863621, udi: (b)(4).W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
Event or Problem Description
On (b)(6) 2014, this patient underwent endovascular treatment for an abdominal aortic aneurysm with a maximum diameter of 108mm and was implanted with gore® excluder® aaa endoprostheses featuring c3® delivery system.The patient tolerated the procedure and was discharged from the hospital on (b)(6) 2014.On (b)(6) 2014, the patient underwent follow-up computed tomography which determined the maximum diameter of the aneurysm measured 92.3mm.On (b)(6) 2019, it was reported the patient had developed a right common iliac artery aneurysm (rcia).On (b)(6) 2022, computed tomography angiography (cta) chest with aorta iliofemoral runoff showed the following: the abdominal aortic aneurysm sac measures up to 8.2 x 4.9 cm in maximum axial dimension and appears similar compared to on (b)(6) 2019.Thrombus within the aneurysm sac appears similar to prior.Slight interval increase in size of a 5.7 x 4.87 m right common iliac artery aneurysm adjacent to the distal limb of the endograft compared to on (b)(6) 2019.There is thrombus within the right external iliac artery aneurysm.There is also a 6 mm saccular aneurysm arising from the posterior left external iliac artery which is similar compared to on (b)(6) 2019.Diffuse calcified and noncalcified atherosclerotic plaque.Both internal iliac arteries are completely occluded.There are areas of hemodynamically significant stenosis in both superficial femoral arteries, described in detail above.There are also areas of stenosis and probable occlusion involving the runoff vessels bilaterally which are not well evaluated.There is two-vessel runoff to the level of the right ankle and single vessel runoff to the level of the left ankle.On (b)(6) 2022, the patient underwent endovascular reintervention at a different facility for a 5cm right common iliac artery aneurysm (rciaa).Aortoiliac angiogram was performed and a right iliac extension limb (medtronic 16 x 13 x 199 mm) was implanted.It was reported that the tortuous bilateral limbs of previous evar, successful placement of stent with no endoleak seen on completion.On (b)(6) 2023, the patient presented at outside facility emergency department with right lower extremity critical limb ischedmia (cli) with arterial embolism, as the right evar limb extension (medtronic) subsequently thrombosed and required limb thrombolysis.On (b)(6) 2022, it was a outside facility reported the patient had a proximal type i endoleak.Cta performed at this time showed following: irregular thrombus along the left side of the endograft more distally which has decreased compared to prior.There is irregular thrombus within the distal left endograft adjacent to the right iliac limb of the endograft which also likely represents residual thrombus.Small amount of thrombus within the proximal right iliac limb of the endograft.The right iliac limb of the endograft is now patent and was completely occluded previously.The right external iliac artery is patent.The right internal iliac is completely occluded proximally and appears similar to prior.There is reconstitution of flow to the more distal branches of the right internal iliac artery.There is also additional graft material along the right iliac branch of the endograft which appears similar to prior.Renal arteries are patent bilaterally.The inferior mesenteric artery is not well visualized and could be occluded.Redemonstrated metallic coils along the origin of the left internal iliac artery.The left internal iliac artery is occluded.The left external iliac artery is patent.On (b)(6) 2022, the patient presented for follow-up at outside facility where open repair of his aneurysm with graft explant was recommended due to the type ia endoleak and risk of rupture.The patient refused explant.

• Brand Name: GORE® EXCLUDER®AAA ENDOPROSTHESIS
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MEDICAL SUNNYVALE B/P; 1327 orleans drive; sunnyvale CA 94089
• Manufacturer Contact: laura crawford ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 16475466
• Report Number: 2953161-2023-01168
• Device Sequence Number: 3150791
• Product Code: MIH
• UDI-Device Identifier: 00733132609888
• UDI-Public: 00733132609888
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2015
• Device Model Number: PXA260300
• Device Catalogue Number: PXA260300
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2023
• Initial Report FDA Received Date: 03/02/2023
• Date Device Manufactured: 07/25/2012
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization; Other
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 90 KG
• Patient Race: White